TPP IP text would restore right to sue surgeons and other medical professionals for patent infringement. Why?

Kista Cox on a provision in the TPP trade negotiation that would restore right to sue surgeons and other medical professionals for patent infringement. The US law (35 USC 287(c)) was changed after lawsuits were filed against surgeons performing certain procedures in eye surgery. USTR and USPTO have been asked to protect this exception in the TPP Intellectual Property Chapter, but have not done so.

In patent law, many countries have excluded "therapeutic and surgical methods for the treatment of humans." This is either done by excluding the patentability of the subject matter, or by providing a limitation on the remedies for infringement.

The language that USTR and USPTO have proposed for the TPP would eliminate the flexibility found in the WTO TRIPS Agreement to "exclude from patentability . . . diagnostic, therapeutic and surgical methods for the treatment of humans or animals."

(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;

The US law permits patents to be granted, but not enforced against a "medical practitioner or against a related health care entity" (see definition below). The US law, sought by the AMA, would permit patent owners to seek damages and other remedies from manufacturers of devices used in surgery, but not against the surgeon or the other medical practitioners or health care entities, for performing a procedure.

The US proposals in the TPP do not permit exceptions to either the granting of patents on the subject matter or the enforcement of the patents against a "medical practitioner or against a related health care entity."

35 U.S.C. 287 Limitation on damages and other remedies; marking and notice.

(c)

(1) With respect to a medical practitioner's performance of a medical activity that constitutes an infringement under section 271(a) or (b) of this title, the provisions of sections 281, 283, 284, and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.

(2) For the purposes of this subsection:

(A) the term "medical activity" means the performance of a medical or surgical procedure on a body, but shall not include (i) the use of a patented machine, manufacture, or composition of matter in violation of such patent, (ii) the practice of a patented use of a composition of matter in violation of such patent, or (iii) the practice of a process in violation of a biotechnology patent.

(B) the term "medical practitioner" means any natural person who is licensed by a State to provide the medical activity described in subsection (c)(1) or who is acting under the direction of such person in the performance of the medical activity.

(C) the term "related health care entity" shall mean an entity with which a medical practitioner has a professional affiliation under which the medical practitioner performs the medical activity, including but not limited to a nursing home, hospital, university, medical school, health maintenance organization, group medical practice, or a medical clinic.

(D) the term "professional affiliation" shall mean staff privileges, medical staff membership, employment or contractual relationship, partnership or ownership interest, academic appointment, or other affiliation under which a medical practitioner provides the medical activity on behalf of, or in association with, the health care entity.

(E) the term "body" shall mean a human body, organ or cadaver, or a nonhuman animal used in medical research or instruction directly relating to the treatment of humans.

(F) the term "patented use of a composition of matter" does not include a claim for a method of performing a medical or surgical procedure on a body that recites the use of a composition of matter where the use of that composition of matter does not directly contribute to achievement of the objective of the claimed method.

(G) the term "State" shall mean any state or territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.

(3) This subsection does not apply to the activities of any person, or employee or agent of such person (regardless of whether such person is a tax exempt organization under section 501(c) of the Internal Revenue Code), who is engaged in the commercial development, manufacture, sale, importation, or distribution of a machine, manufacture, or composition of matter or the provision of pharmacy or clinical laboratory services (other than clinical laboratory services provided in a physician's office), where such activities are:

(A) directly related to the commercial development, manufacture, sale, importation, or distribution of a machine, manufacture, or composition of matter or the provision of pharmacy or clinical laboratory services (other than clinical laboratory services provided in a physician's office), and

(B) regulated under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or the Clinical Laboratories Improvement Act.

(4) This subsection shall not apply to any patent issued based on an application the earliest effective filing date of which is prior to September 30, 1996.